On March 5, 2021 Vaccibody AS, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that Vaccibody has decided to change its financial reporting from NGAAP (Norwegian Generally Accepted Accounting Principles) and instead adopt IFRS (International Financial Reporting Standards) as its new accounting standard (Press release, Vaccibody, MAR 5, 2021, View Source [SID1234576141]).

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Vaccibody has experienced a continued growing international interest in its stock, including a significant increase in its international investor base which has led to the Company’s decision to change its accounting standard to IFRS. The above change will be adopted with effect from the Company’s annual report as of the financial year 2020.

In addition, Vaccibody has initiated a process to explore a possible listing of Vaccibody on the Nasdaq Global Market in the United States. This process reflects the continued clinical and strategic advancement of Vaccibody’s portfolio of innovative vaccines and novel immunotherapies as well as the growing interest of international investors in Vaccibody. The timing of any potential listing will be considered as part of this review process and any potential listing would be subject to prevailing equity capital markets conditions at such possible relevant time.

On March 5, 2021 ViewRay, Inc. (NASDAQ: VRAY) (the "Company") reported that members of management will be participating in the 21st Annual Oppenheimer Healthcare Conference on Tuesday, March 16, 2021 (Press release, ViewRay, MAR 5, 2021, View Source [SID1234576160]). ViewRay will be conducting a virtual fireside chat at 3:50 PM ET, as well as hosting 1×1 meetings with investors.

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A live webcast of the Company’s fireside chat will be available on the "Financial Events and Webinars" section of ViewRay’s investor website at: View Source A replay of the presentation will be available for the following 7 days.

On March 5, 2021 Illumina, Inc.’s (NASDAQ: ILMN) reported NextSeq 550Dx platform and associated reagent kits received medical device registration in Russia, as have reagents for the MiSeqDx which was approved previously as a medical device (Press release, Illumina, MAR 5, 2021, View Source [SID1234576123]). Both of these in vitro diagnostic (IVD)-ready solutions are available to customers and third-party developers to create diagnostic solutions using the technology. These registrations will catalyze the expansion of sequencing-based clinical diagnostics across the country.

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Sequencing platforms, and the reagents that drive them, must be approved separately in Russia by the medical device regulatory agency, Roszdravnadzor. Illumina’s strategic partner in Russia and CIS, R-Pharm, led the regulatory process and this is the first approval of complete sets of sequencing instruments plus reagents.

"Having the two IVD-platforms available to assay developers to expand the clinical use of Next Generation Sequencing-based (NGS) molecular diagnostics will be a great boost to testing for genetic diseases and oncology in Russia," said Paula Dowdy, Senior Vice President and General Manager of Illumina, Europe Middle East and Africa. "The NextSeq 550Dx is ideal for high throughput sequencing at large, federal hospitals, and the desktop MiSeqDx is well suited to the laboratory facilities of standard clinical centers."

"These registrations are a significant step in bringing NGS technologies closer to patients, many of whom live near the smaller municipal and regional clinics. Bringing NGS diagnostics, with accurate and validated results, will be a huge benefit to patients," said deputy Director General of the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology, Professor Mikhail Maschan.

Director of the Tomsk National Research Medical Center, correspondent member of the Russian Academy of Sciences, Vadim Stepanov, said: "Genetics and molecular biology are the core of clinical science because the majority of diseases originate from genetic mechanisms in cells, tissues and organs. Registration of Illumina’s products as medical devices allows to add the most modern technologies to clinical practice."

"We are pleased that our partnership with Illumina, a global leader in human genome sequencing, will help Russian patients benefit from improved diagnosis and precision healthcare," said Alexey Repik, R-Pharm Chairman of the Board.

On March 5, 2021 Seagen Inc. (Nasdaq:SGEN) reported that it has been notified of an unsolicited "mini-tender" offer dated February 22, 2021, made by TRC Capital Investment Corporation, an Ontario, Canada corporation, to purchase up to 1,000,000 shares of Seagen’s common stock (Press release, Seagen, MAR 5, 2021, View Source [SID1234576145]). According to TRC, its "mini-tender" offer price of $151.00 per share was approximately 4.28% below the closing price of Seagen’s common stock on February 19, 2021, the last trading day prior to the date of its offer.

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Seagen does not endorse TRC Capital’s unsolicited "mini-tender" offer and is not associated in any way with TRC Capital, its "mini-tender" offer, or its "mini-tender" offer documents. Seagen recommends that Seagen shareholders reject the offer and not tender their shares in response to this unsolicited offer, for the reasons described below.

TRC has made many similar "mini-tender" offers for the shares of other companies. "Mini-tender" offers are designed to seek less than five percent of a company’s outstanding shares, thereby avoiding many disclosure and procedural requirements of the U.S. Securities and Exchange Commission (SEC) because they are below the SEC’s threshold to provide such disclosure and procedural protections for investors.

The SEC has cautioned investors about "mini-tender" offers in an investor alert. The SEC noted that these offers "have been increasingly used to catch investors off guard" and that many investors who hear about "mini-tender" offers "surrender their securities without investigating the offer, assuming that the price offered includes the premium usually present in larger, traditional tender offers."

To read more about the risks of "mini-tender" offers, please review the alert on the SEC’s website at View Source

TRC’s "mini-tender" offer is subject to numerous conditions, including TRC obtaining sufficient financing available to consummate the offer on terms satisfactory to TRC in its reasonable discretion. Seagen urges shareholders to obtain current stock quotes for their shares of Seagen common stock, review the terms and conditions to the offer, consult with their broker or financial adviser and exercise caution with respect to TRC Capital’s "mini-tender" offer. Shareholders who have already tendered shares should consider the advisability of withdrawing their shares as permitted under TRC’s Offer to Purchase documents.

According to the offer documents, the offer is currently scheduled to expire at 12:01 a.m., Eastern time, on March 23, 2021.

Seagen requests that a copy of this news release be included with all distributions of materials relating to TRC’s "mini-tender" offer related to shares of Seagen’s common stock.

On March 5, 2021 TerSera Therapeutics LLC reported the presentation of data from their Phase 2 study of intravenous (IV) cetirizine versus IV diphenhydramine in the prevention of hypersensitivity infusion reactions in patients with breast cancer and other malignancies (Press release, TerSera Therapeutics, MAR 5, 2021, View Source [SID1234576161]). The data were presented in virtual poster sessions during the 38th Annual Miami Breast Cancer Conference on March 4-7, 2021.1

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The Phase 2 exploratory study was a randomized, double-blind, study evaluating the prevention of infusion reactions with cetirizine hydrochloride injection 10mg/mL for IV use versus IV diphenhydramine 50 mg in 34 patients receiving paclitaxel or an anti-CD20 Ab (rituximab, its biosimilar or obinutuzumab). In the IV cetirizine group compared to the IV diphenhydramine group, the number of patients with infusion reactions were 2/17 (11.8%) versus 3/17 (17.6%); sedation scores (range 0 – 4) at 1 hour, 2 hours, and discharge were 0.5, 0.6, and 0.1 versus 1.3, 0.9, and 0.4. Time for discharge was 24 minutes less with IV cetirizine versus IV diphenhydramine. The number of treatment-related adverse events were 3 events with IV cetirizine and 6 events with IV diphenhydramine.

"We are pleased with the results of this Phase 2 study," said Nancy Joseph- Ridge, M.D., Executive Vice President of Research and Development and Chief Medical Officer of TerSera Therapeutics. "This is the first study of IV cetirizine compared to IV diphenhydramine for the prevention of infusion reactions, an investigational use of IV cetirizine."

QUZYTTIR is the first and only injectable second-generation H1 antihistamine to be approved by the U.S. Food and Drug Administration (FDA).2 QUZYTTIR is indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

QUZYTTIR is not approved for the prevention of infusion reactions.

Important Safety Information about QUZYTTIR:

INDICATIONS AND USAGE
QUZYTTIR is indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

Limitations of Use: QUZYTTIR is not recommended in pediatric patients <6 years of age with impaired renal or hepatic function.

Contraindications: Known hypersensitivity to QUZYTTIR or any of its ingredients, to levocetirizine, or hydroxyzine.

Additional Warnings and Precautions: The occurrence of somnolence/sedation has been reported in some patients. Advise patients to exercise due caution when driving or operating potentially dangerous machinery. Avoid concurrent use of QUZYTTIR with alcohol or other CNS depressants because additional reduction in alertness and additional impairment of CNS performance may occur.

Adverse Reactions: The most common adverse reactions (incidence <1%) with QUZYTTIR are dysgeusia, headache, paresthesia, presyncope, dyspepsia, feeling hot, and hyperhidrosis.

The most common adverse reactions (incidence ≥2%) with chronic dosing of oral cetirizine hydrochloride in adults are somnolence, fatigue, dry mouth, pharyngitis and dizziness. Adverse reactions observed in pediatric patients with chronic use of oral cetirizine hydrochloride are headache, pharyngitis, abdominal pain, coughing, somnolence, diarrhea, epistaxis, bronchospasm, nausea, and vomiting.